MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study (NCT02908880) | Clinical Trial Compass
CompletedNot Applicable
MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study
United States263 participantsStarted 2016-12
Plain-language summary
Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure. The MANTA device is expected to seal the femoral access puncture in less than 1 minute. This may result in less blood loss and a shorter time to walking compared to alternative closure means. Use of the MANTA device in this study is experimental. All other parts of the procedure involve standard medical care.
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedure via a 10-18F size retrograde common femoral artery approach (i.e., transcatheter aortic valve implantation \[TAVI\], endovascular aneurysm repair \[EVAR\], Impella® use)
✓. Vessel size would allow for access for the MANTA device as determined by baseline CTA: minimum vessel diameter 5mm for the 14F MANTA and 6mm for the 18F MANTA
✓. Eligible for sheath removal in the catheterization lab
✓. Age ≥21 years
✓. Understand and sign the study specific written informed consent form
✓. Able and willing to fulfill the follow-up requirements
✓. In the investigator's opinion, patient is suitable for the MANTA vascular closure device, conventional hemostasis techniques and participation in an investigational trial
Exclusion criteria
✕. Known to be pregnant or lactating
✕. Immunocompromised or with pre-existing autoimmune disease
✕. Systemic infection or a local infection at or near the access site
✕. Known bleeding disorder including thrombocytopenia (platelet count \<100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
✕. Allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel
✕. Femoral artery puncture in target groin within the prior 14 days